MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE; ROLLATOR

Model Number RTL10266BK

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney, who stated "the end user suffered injuries to their right foot, requiring a toe amputation as a result of his use of the nitro euro style rollator." drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no.1,benting; bentsuo villge; sikao township, jiayi county chiayi 62348 ; TW 62348
• MDR Report Key: 17330347
• MDR Text Key: 319185979
• Report Number: 2438477-2023-00093
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383523927
• UDI-Public: 822383523927
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266BK
• Device Catalogue Number: RTL10266BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2023
• Distributor Facility Aware Date: 07/14/2023
• Date Report to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male